Robotic Versus Hybrid Assisted Ventral Hernia Repair (ROHYB)

Kuopio University Hospital

Status: Enrolling

Conditions: Quality of Life; Pain; Recurrence

Treatments: Device: robotic; Device: hybrid

Study type: Interventional

Funder types: Other

Identifiers

NCT05233020

5200662

Details and patient eligibility

About

Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).

Full description

Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ventral hernia size 3-6 cm

Exclusion criteria

• previous ventral hernia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Robotic

Experimental group

Description:

Fifteen patients undergo rVHR operation.

Treatment:

Device: robotic

hybrid

Experimental group

Description:

Fifteen patients undergo hybrid operation.

Treatment:

Device: hybrid